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Further assess the performance and safety profile of the commercially available Portico Valve implanted, using the Delivery System and the Loading System, in patients with severe symptomatic aortic stenosis.

Patients implanted with a Portico valve bearing the CE mark (implanted after St Jude Medical declared the device "compliant" with all applicable essential requirements within the European union and marketed the device bearing the CE mark.)

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Patients that are candidates for implantation of a St Jude Medical Portico replacement aortic heart valve, or have been implanted with with a St. Jude Medical Portico valve as part of a previous investigational device trial

Criteria

Inclusion Criteria:

Patient has signed the Patient Informed Consent prior to participating in the clinical investigation.

Patient has been referred for a Portico Valve implant as per Heart Team decision.

Patient has senile degenerative aortic stenosis with an initial valve area of less than (<) 1.0 cm2 (or aortic valve area index less than or equal to (≤) 0.6 cm2/m2) AND a mean transvalvular gradient greater than (>) 40mmHg or jet velocity greater than (>) 4.0 m/s derived by resting echocardiogram [or dobutamine stress echocardiogram if subject has a left ventricular ejection fraction (LVEF) < 50%]. (Baseline measurement taken by echo within 45 days of index procedure).

Patient has a life expectancy more than (>) 12 months.

Exclusion Criteria:

Any case in which the Portico Valve would not be indicated for the patient as per current instructions for use (i.e any "off-label" use).

Patient has any other than tricuspid valve.

Patient has a prosthetic valve or ring in the aortic position.

Patient needs a concomitant structural heart procedure.

Patient needs the usage of an embolic protection device.

Patient is unwilling or unable to comply with all clinical investigation-required follow-up evaluations.

Patient is pregnant

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802788